Despite the incontrovertible evidence emphasizing the negative sequelae of untreated pain, children, particularly those who are cognitively impaired, remain vulnerable to unrelieved pain due to significant gaps in research and practice. Difficulties assessing pain and beliefs that individuals with cognitive impairment have altered or blunted pain perception have led to their virtual exclusion from pain-related clinical trials and to the observed disparities in their treatment. Studies have shown that most children with cognitive impairment are unable to self-report their pain or to seek relief from pain. It is therefore imperative that care providers be able to assess pain using valid and reliable methods so that appropriate interventions may be initiated. This application is designed to evaluate the reliability, validity, and clinical utility of the Faces Legs Activity Cry and Consolability (FLACC) observational pain tool as a measure of pain in children with cognitive impairment. Existing data, videotaped observations, evidence from recent literature, and expert opinion have been used to refine the FLACC tool for this population. Children with cognitive impairment will be observed and videotaped postoperatively prior to and following analgesic administration. These observations will be used to determine interrater and test-retest reliability, construct validity, specificity, and sensitivity of the FLACC tool. Clinical utility will be evaluated by the opinion of experts from three institutions who will also view videotaped observations. The primary goal of this project is to refine the FLACC tool to improve its validity and reliability as a measure of pain in children with cognitive impairment. This will, in turn, provide an immediate means to improve clinical pain management in this vulnerable population. The U.S. Department of Health and Human Services has recognized significant gaps in scientific knowledge that impede health care advances in individuals with mental retardation. Failure to address such gaps in the area of pain management places those with cognitive deficits at risk for ongoing needless suffering. This study is the crucial first step toward eliminating the glaring deficiencies in pain management for individuals with cognitive impairment. This work will provide the platform on which to base further study of pain management practices in this underserved population. A reliable and valid pain assessment tool is critical to facilitate our future study of pain management strategies in these children.